KR20180078258A - Wound treatment devices and methods - Google Patents

Abstract

A wound treatment device and method includes a skin contact element, a reactor, and a reactor housing element. The skin contact element is configured to cover an associated tissue site, a reactor for creating a pressure condition at the tissue site associated with the operation, and a reactor housing element for receiving the reactor. The skin contact element has a skin contact surface and a boundary surface opposite to the skin contact surface. The reactor housing element has a lower mounting surface and an upper surface opposite the lower mounting surface.

Description

Wound treatment devices and methods

Negative pressure is a term used to describe pressure below normal atmospheric pressure. At room temperature and at sea level, the volume of defined air contains molecules moving in random directions, and these moving molecules apply a force equal to the normal atmospheric pressure of about 756 mmHg (about 1 bar). Sound pressure has been achieved by removing air from the area of interest, for example through the suction pump, at the wound site. Devices for the generation of localized negative pressure on the subject's skin surface have been used for hundreds of years to treat humans. For example, the technique of depression associated with placing the mouth of solid air containing hot air on human skin is a well known technique. Spring powered syringes and suction cups are other mechanical techniques that have been used to create a partial vacuum on human tissue. As with the subsection, such other mechanical techniques provide a limited local sound pressure period and provide little or no range of neutral or positive pressures. This is due to the fact that design constraints and subordinate techniques and other mechanical techniques are not self-contained and can interfere with user mobility.

Known local sound pressure devices include fluid-permeable wound cavity filling elements, covering dressings, rational hermetic means for sealing against skin, and wound areas and cavity filling elements To wound treatments involving drainage tubes that connect to a vacuum source through a fluid collection canister. The mode of operation of such devices is to apply a negative pressure to the tissue site, which causes the expansion of the closed tissue into the cavity, which is made possible by sealing the device against the skin. If the treated tissue site is a wound, the effluent can be drawn from the surrounding tissue through the porous cavity filler, into the drainage tubing, and then into the remote collection vessel. Such known device considerations are the ability of the wound cavity filler to remain sufficiently porous to allow fluid to be transported from the tissue site to drain or aspirant tube when compressed under negative pressure.

To enable longer-term application of localized sound pressure, powered systems have been developed, including vacuum generating sources such as pumps, and many examples of such systems have been used today for recovery purposes such as temporary removal of skin treatments and wrinkles Is used. However, many of these systems are not convenient for users. Such known systems are large, heavy, loud and inconvenient, and may not be simple for users to apply and initiate controlled pressure conditions. Such known systems also rely on an external power source or a vacuum source to produce local negative pressure conditions.

Such tissue therapies, surgery, and other advanced technological interventions are becoming more common, given the increasing incidence of both aging populations as well as increasingly impaired patient populations. This trend is expected to continue. In the case of wounds, for example, healthcare professionals are now more likely to encounter difficulties to manage with complicated healing problems. Attempts have been made to produce simpler mechanical devices that can apply local and negative pressure to tissue sites. It will be appreciated that such a medical device would be expected to reduce material costs and assembly costs due to the simplicity of its relative design. For example, attempts have been made to use hand-pump systems to apply localized sound pressure to tissue sites. However, such a system does not allow easier application by the user, careful use, and long-term convenient application of local sound pressure, and in fact, re-exhaustion is often necessary. These can be serious deficiencies, especially as many such systems may be ideally usable during long periods of time such as overnight.

According to one aspect, a wound treatment device includes a skin contact element, a reactor, and a reactor housing element. The skin contact element is configured to cover an associated tissue site, a reactor for creating a pressure condition (pressure condition) at the tissue site associated with the operation, and a reactor housing element for receiving the reactor. The skin contact element has a skin contact surface and a boundary surface opposite to the skin contact surface. The reactor housing element has a lower mounting surface and an upper surface opposite the lower mounting surface. The reactor housing element is configured to attach to the skin contact element after the reactor is activated.

According to another aspect, a wound treatment device includes a skin contact element, a reactor, a reactor housing element and an air permeable liquid impermeable membrane. The skin contact element is configured to cover an associated tissue site, a reactor for generating a pressure condition at the tissue site associated with the operation, and a reactor housing element for receiving the reactor. The skin contact element has a skin contact surface and a boundary surface opposite to the skin contact surface. The reactor housing element has a lower mounting surface and an upper surface opposite the lower mounting surface. The air-permeable liquid impermeable membrane is arranged on the exposed surface of the reactor so as to be interposed between the reactor and the skin-contacting element when the reactor housing element is attached to the skin-contacting element.

According to yet another aspect, a wound treatment device includes a skin contact element, a reactor, and a reactor housing element. The skin contact element is configured to cover an associated tissue site, a reactor for generating a pressure condition at the tissue site associated with the operation, and a reactor housing element for receiving the reactor. The skin contact element has a skin contact surface and a boundary surface opposite to the skin contact surface. The reactor housing element has a lower mounting surface and an upper surface opposite the lower mounting surface. The reactor housing element is removably attached to the skin contact element to enable removal of the reactor housing element and replacement of one or both of the reactor and reactor housing elements.

According to a further aspect, a method for applying a controlled pressure to a tissue site comprises: covering a tissue site with a skin contact element; Attaching the reactor housing element to the skin contact element; And operating the reactor to create a pressure state at the tissue site. The skin contact element has a skin contact surface and a boundary surface opposite to the skin contact surface. The step of covering the tissue site with the skin contact element includes a skin contact surface arranged to face the tissue site. The reactor housing element has a reactor accommodated therein. The reactor housing element also has a lower mounting surface and an upper surface opposite the lower mounting surface. The step of attaching the reactor housing element to the skin contact element occurs after the step of operating the reactor.

1 is a schematic exploded perspective view of a control pressure device according to an exemplary embodiment.
1A is a schematic exploded perspective view of another skin contacting element in an alternative exemplary embodiment.
Figure 2 is a schematic cross-sectional view of the control pressure device shown in Figure 1;
2A is a schematic cross-sectional view of a control pressure device similar to that shown in FIG. 2 but according to an alternative exemplary embodiment.
Figures 3 and 4 schematically illustrate reactors in accordance with alternative exemplary embodiments.
5-7 schematically illustrate power components in accordance with alternative exemplary embodiments for use with the control pressure device of FIG.
8 is a block diagram of a method for applying controlled pressure to a tissue site in accordance with an exemplary embodiment.

Figure 1 shows a control pressure device 10 according to an exemplary embodiment, which may also be referred to as a wound treatment device or a self-contained wound treatment device. The wound treatment device 10 includes a skin contact element 12, a reactor housing element 14, and a reactor 16. 2, the wound treatment device 10 also includes a wound contact element 20 for direct contact with the tissue site 20, and in particular for direct contact with the wound or treatment site 20a at the tissue site 20, (18). As will be described in more detail below, wound treatment device 10 includes a tissue (including but not limited to tissue), including but not limited to wound healing (e.g., healing of wound portion 20a), reduction of skin wrinkles, May be located in the tissue site 20 to improve treatment. The skin contacting element 12 is configured to cover the associated tissue site 20 and, in particular, to cover the wound area 20a of the tissue site 20, as will be described in more detail below. As used herein, a tissue site is referred to as an associated tissue site so that the tissue site itself (and the wound site 20a of the tissue site) is not generally considered a component of the wound treatment device 10. A reactor housing element 14 is provided to receive the reactor 16 and a reactor 16 is provided to receive the associated tissue site 20 during its operation (i.e., operation of the reactor 16) to act on the wound site 20a. Lt; / RTI > is provided to generate a pressure condition at the outlet. The wound contact element 18 is provided for direct contact with the wound portion 20a at the tissue site 20 (i.e., the contact element 18 is interposed between the skin contact element 12 and the wound portion 20a ).

In one embodiment, the reactor housing element 14 is configured to attach to the skin contact element 12 after the reactor 16 has been activated. Permeable membrane (e. G., Membrane 100) may be provided to inhibit or limit the exudate from the tissue site 20 reaching the reactor 16 have. In these or additional embodiments, the skin-contacting element 12 is configured such that when the reactor element 14 is changed, for example, when the reactor 16 is sufficiently consumed and a new reactor 16 is required, . In these and other embodiments, the wound treatment device 10 is self-contained in that it does not need to be connected to external power and / or vacuum sources as opposed to many prior art devices.

The skin contact element 12 includes a skin contact surface 30 that is attachable to the subject's skin (e.g., around the wound area 20a), and a boundary surface 32 that is opposite the skin contact surface 30. In the illustrated embodiment, the skin contact element 12 is shown as an element separate from the reactor housing element 14. In an alternative arrangement, the skin-contacting element 12 may be provided as part of the reactor housing element 14, for example, the skin-contacting element 12 may be integrally formed with the reactor housing element 14 in the manufacturing facility Or may be connected to the reactor housing element 14 and the elements 12,14 may be applied together to the tissue site 20. In the illustrated embodiment, the skin contacting element 12 is a flexible material that allows the wound treatment device 10 to conform to the skin of the subject placed at and / or around the tissue site 20 (e.g., , A thin gas impermeable film). The skin contact element 12 may be made of a thin sheet-like membrane (e.g., a thin gas impermeable film), for example, using a roll-to-roll process.

In the illustrated embodiment, the skin contacting element 12 is also referred to herein as skin contact element openings, alternatively referred to herein as " skin contacting element openings ", which extend through the skin contacting element 12 from the skin contacting surface 30 to the interface surface 32. [ (Not shown). The skin contact element openings 34 are arranged for positioning on the tissue site 20 and above the wound area 20a in particular and the pressure state produced by the reactor 16 is applied to the skin contact element openings & To the tissue site 20, and more particularly to the wound site 20a, via the distal end 34 of the wound. The one or more openings 34 may be used to control or limit the rate of scavenging by the reactor 16. For example, the number of openings 34 and / or the size of the openings 34 (i.e., the surface area of the openings) can effectively limit the amount of air reaching the reactor 16, It is possible to control the speed of consumption by the user. In addition to controlling the pressure conditions produced by the reactor 16, it can also control the amount or rate of heat produced by the reactor 16. [

1A, the skin-contacting element 12a may be replaced with a skin-contacting element 12, and the skin-contacting element 12a may be replaced from the skin-contacting surface 30a to the interface surface 32a, A single opening 34a extending through the opening 34a. The openings 34a may be arranged for positioning (e.g., on or about) the tissue site 20. Alternatively, the skin contacting element 12a and / or the single opening 34a may be dimensioned to fit around the wound portion 20a of the tissue site 20. In one exemplary application, the skin contacting element 12a is used when it is desired to change and / or change the wicking element 36 (e.g., a new wicking element) It can stay in place.

A wound contact element 18, also referred to herein as a wound contact layer, is an open mesh that minimally adheres to a damaged skin tissue (e.g., a wound portion 20a in tissue site 20) As shown in FIG. In one embodiment, the wound contact element 18 may itself be attached to the broken skin tissue minimally and / or may include an antimicrobial component (e.g., silver, chlorohexidine gluconate (CHG), etc.) A loose nylon fabric flood coated on its backside 18a with a coating 22 or an open mesh polyurethane film (e.g., a 1 mm polyurethane film). For example, the coating 22 may be silicon, nylon, or the like.

The wound treatment device 10 may further include a wicking element 36. [ As will be described in greater detail below, the wicking element 36 is adapted to receive exudate from the tissue site 20 when the pressure state is at a negative pressure (e. G., Evacuates air or oxygen) from the tissue site 20, . The wicking element 36 may have suitable liquid retention properties to absorb the amount of exudate from the tissue site 20. In one embodiment, the wicking element 36 is formed of a suitable wicking material capable of withstanding an external pressure of up to about 3 psi (i.e., about 0.2 bar). In the same or another embodiment, the wicking element 36 may maintain its shape under pressure (e.g., at 0.2 bar) or it may expand as it absorbs the exudate. The wicking element 36 may be arranged to be interposed between the reactor 16 and the tissue site 20 when the wound treatment device 10 is applied to the tissue site 20. In other embodiments,

The position of the wicking element 36 relative to other components of the wound treatment device 10 may vary. For example, the wicking element 36 may be located above or below the skin contacting element 12. [ In the embodiment shown in FIG. 2, the wicking element 36 is located above the skin contact element 12 and below the reactor 14. In this embodiment, the wicking element 36 may, for example, be provided with the reactor element 14 (e.g., located between the release layer 70 and the reactor 16) or as part of the reactor 14 (E. G., Between substrate 80 and bottom layer 86). Alternatively, a wicking element may be provided along with the skin contact element 12 (e.g., between the release layer 50 and the skin contact element 12 And optionally the wicking element 36 may be provided as a separate element that is assembled onto the skin-contacting element (e.g., attached to the wicking element 32) 36 may be individually packaged, removed from its packaging, and assembled or laminated onto the interface 32). 2a, a wicking element is provided with a skin-contacting element and interposed between the backside 30 of the skin-contacting element 12 and the wound-contacting element 18. In the embodiment shown in Fig.

The wicking element 36 may be sized for one or more openings 34 (or the opening 34a of the skin contacting element 12a). The wicking element 36 may also be arranged or sized such that a pressure state is applied to the tissue site 20, and in particular to the wound site 20a, via or through the wicking element 36. [ For example, the wicking element 36 may be larger than the footprint area defined by the one or more openings 34. For example, 1A, openings 34 and skin-contacting element 12a are shaped similarly to wicking element 36 and are arranged such that skin-contacting element 12a is disposed about wicking element 36. In other embodiments, Lt; / RTI > For example, the wicking element 36 may provide an interference fit between the wicking element and the skin-contacting element 12a (i.e., portions of the skin-contacting element 12a forming the opening 34a) Or may be sized such that there is no gap between the outer periphery of the wicking element 36 and the skin-contacting element 12a. In addition, the wicking element 36 may be larger than the opening 34a to overlap or underwrap the skin-contacting element 12a.

Both skin contact surface 30 and interface 32 may be generally flat or planar, but skin contact element 12 is flexible and conforms to contours in tissue site 20, as indicated above . In the illustrated embodiment, interface 32 is the upper surface of skin contact element 12 and skin contact surface 30 is the lower surface of skin contact element 12 (i.e., lower than interface surface 32) Thus being located closer to the tissue site 20). Similarly, the wound contact element 18 may have a back side 18a and a top side 18b, both of which may be flat or planar, but both are flexible and conform to the contours at the tissue site 20 can do.

The wound healing device 10 may be positioned on or adjacent to the skin contacting surface 30 of the skin contacting element 12 to adhere or seal the skin contacting element 12 to and / (E. G., Seal 40 and glue 42) to be placed thereon. In the illustrated embodiment, at least one skin adhesive or seal element is configured to seal the skin contact element 12 around the tissue site 20 such that a pressure condition created by the reactor 16 is applied to the tissue site 20 Or an ambient pressure seal 40, also referred to herein as a gasket. In particular, as shown in FIG. 2, the peripheral pressure seal 40 may seal the wound contact element 18 and the skin contact element 12 to the tissue site 20. In addition, or alternatively, at least one skin adhesive or sealing element may be or include an adhesive 42 that adheres the skin contacting element 12 to and / or around the tissue site 20. In particular, as shown in FIG. 2, adhesive 42 is provided around the periphery pressure seal to adhere skin contacting element 12 to tissue site 20.

The seal or gasket 40 may be made of a hydrogel to further promote sealing around the tissue site 20 and thereby promote pressure conditions (e.g., localized negative pressure) at the tissue site 20. The adhesive 42 may be, for example, a biocompatible acrylic adhesive that is flood coated onto the skin-contacting surface 30 of the skin-contacting element 12. In one embodiment, the adhesive 42 is layered (e.g., flood-coated thereon) on the skin-contacting surface 30 of the skin-contacting element 12 and the scratch- Is overlaid onto the contact surface 30 and the seal 40 is applied as a peripheral bead (e.g., a bead of hydrogel) on the adhesive 42 at the location of the peripheral edge 18c of the wound contact element 18. [ The size and / or width of the seal 40 may vary. In an alternative embodiment, although not shown, the seal 40 may be provided as a plurality of seals, e.g., for example, a plurality of concentric rings.

In order to protect and / or package the skin contact element 12 and wound contact element 18 (and optionally the wicking element 36), a first skin, also referred to herein as a tear-off barrier element, The contact element releasing layer 44 is formed on the skin contact surface 30 of the skin contact element 12, the back surface 18a of the wound contact element 18 and optionally the wicking element 36 (E.g., provided with the skin contacting element 12). ≪ / RTI > In particular, the release layer 44 may be disposed on the skin-contacting surface 30 of the skin-contacting element 12 and above the wound-contacting element 18. The release layer 44 may be removable to expose the adhesive 42 and / or the peripheral pressure seal 40 provided on the skin-contacting surface 30 of the skin- The release layer 44 includes an upper surface 46 that can be similar to known release layers and is releasable from the skin contact surface 30 of the skin contact element 12. The release layer 44 may also include a bottom surface 48 that is opposite the top surface 46. In one embodiment, release layer 44 is removably secured to skin contact surface 30 through a polyurethane film (not shown). Optionally, the seal 40 is not provided below the release layer 44, but is applied later after the release layer 44 has been removed.

Optionally, the second skin contact element releasing layer 50, also referred to herein as an interfacial release layer, is used to protect the interface surface 32 and the wicking element 36 of the skin- May be provided with the device 10. In particular, the release layer 50 may be disposed on the interface surface 32 of the skin contact element to provide a skin contact element as a first package component that is separate from the reactor housing element 14 and the reactor 16, Which may be provided together as a second package component. For example, release layer 50 may be provided with skin contact element 12 and wound contact element 18 may be provided and / or packaged separately for reactor housing element 14 and reactor 16. The release layer 50 may be similar to the release layer 44. For example, the release layer 50 may be disposed on the interface 32 of the skin contact element. The release layer 50 may be removable to expose the interface 32. In particular, the release layer 50 may include a lower surface 54 opposite the upper surface 52 and a releasable upper surface 52 from the interface surface 32 of the skin-contacting element 12. Alternatively, the release layer 50 may also protect the wicking element 36 when the wicking element 36 is provided with and / or packaged with the skin-contacting element 12.

The reactor housing element 14 is configured to allow the skin contacting surface 30 of the skin contacting element 12 to contact the subject's skin when the skin contact surface 30 contacts the subject's skin (i.e., at and / or around the tissue site 20, Cooperates with the skin contact element 12 to define a closed volume 56 at and / or around the tissue site 20 (when adhered to and / or around the tissue site 20). Thus, in the illustrated embodiment, the reactor housing element 14 defines an enclosed volume 56 in which the reactor 16 is accommodated. The reactor housing element 14 of the illustrated embodiment includes a hood or hood portion 58 and a lower peripheral section 60. In the illustrated embodiment, the lower peripheral section 60 generally surrounds the hood 58, which allows the skin-contacting element 12 to be closed and / or sealed around the tissue site 20 when and / Is raised with respect to the lower peripheral section 60 to define the < RTI ID = 0.0 > The reactor housing element 14 allows the air to pass through the enclosed volume 56 as the reactor 16 consumes one or more selected gases in the enclosed volume 56 and thereby reduces the gas pressure within the enclosed volume 56. [ Impermeable or partially impermeable material so as to be excluded or substantially prohibited from entering inside.

In alternative embodiments, the reactor housing element 14 may be at least partially impermeable to certain gases (e.g., oxygen) and may be at least partially permeable to other gases (e.g., carbon dioxide, nitrogen, etc.) ≪ / RTI > For example, the reactor housing element 14 may be made of a material that discharges a higher proportion of specific gases relative to other gases than occurs with direct communication to the environment. Alternatively, for example, the reactor housing element 14 may be at least partially (or more) adapted to gases selected relative to other gases to exhaust or better exhaust selected gases from the tissue site 20 to the atmosphere. May be formed of a material that is gas permeable (e.g., nitrogen or carbon dioxide gas permeable).

The reactor housing element 14 may also be formed without the hood 58, i.e., the reactor housing element 14 may be at least initially planar, as shown in FIG. Similar to the skin contact element 12, the reactor housing element 14 can be made of a thin sheet-like membrane, for example, using a roll-to-roll process. The reactor housing element 14 may be made of a flexible material similar or identical to the skin contact element 12 which allows the wound treatment device 10 to conform to the skin around the tissue site 20. When the reactor housing element 14 is attached to the skin contact element 12, the reactor 16 is positioned between the reactor housing element 14 and the skin contact element 12. A wicking element 36, which may be located in one of several different positions within the wound treatment device 10 as described above, is interposed between the reactor 16 and the skin contacting element 12. The section of the reactor housing element 14 that is not in contact with the skin contacting element 12 may be raised or lowered from the tissue site 20 to form the hood 58 Offset.

The reactor housing element 14 includes a lower mounting surface or surface 62 and an upper surface 64 opposite the lower mounting surface 62. As will be described in greater detail below, the reactor housing element 14 is formed on the interface surface 32 of the skin contact element 12 that provides a substantially hermetic seal between the reactor housing element 14 and the skin contact element 12 . This can eliminate air movement between or along the boundary between the lower surface 62 of the reactor housing element 14 and the interface surface 32 of the skin contact element 12. In one embodiment, the reactor housing element 14 is provided as a separate component to the skin contacting element 12. In another embodiment, the reactor housing element 14 is already provided with the skin contact element 12 assembled.

For a boundary between the reactor housing element 14 and the skin contact element 12, the wound treatment device 10 includes a skin contact element 12 for adhering or sealing the reactor housing element 14 to the skin contact element 12, (E.g., a peripheral pressure seal 66 and / or an adhesive 68) interposed between the reactor housing element 14 and the reactor housing element 14. [ In one embodiment, at least one of the reactor adhesive or sealing elements includes or includes a peripheral pressure seal 66, also referred to herein as a gasket, that seals reactor housing element 14 against skin contact element 12 . In the same or alternative embodiments, at least one of the reactor adhesive or sealing elements includes an adhesive 68 that adheres the reactor housing element 14 to the skin-contacting element 12. Seal 66 may be similar to seal 40, including alternative embodiment (s) described in connection with seal 40. For example, the seal 66 may be made of a hydrogel to further promote the sealing between the skin contact element 12 and the reactor housing element 14 thereby thereby improving the application of the pressure state at the tissue site 20. [ And the adhesive may be formed as a layer on the lower mounting surface 62 of the lower peripheral section 60 of the reactor housing element 14 while the seal 66 is applied as a peripheral bead over the adhesive layer.

When the reactor housing element 14 is separately provided and / or packaged relative to the skin contact element, the wound treatment device 10 has a lower attachment surface 62 (FIG. 6) of the reactor housing element 14 to protect the lower attachment surface 62 And a reactor housing release layer 70 disposed over the reactor 16 to protect the reactor 16 and / or inhibit the operation of the reactor 16. [ The release layer may be the same or similar to the release layers 44, 50. The release layer 70 is removable to expose the reactor 16 that is received by the reactor housing element 14 to operate the reactor 16 as will be described in more detail below. The release layer 70 may include a top surface 72 releasable from the bottom attachment surface 62 of the reactor housing element 14 and a bottom surface 74 opposite the top surface 72.

The reactor 16 may be located in the enclosed volume 56 and may contain at least one selected gas found in the air to consume at least one selected gas in the enclosed volume 56, Carbon dioxide, etc.), which can reduce the gas pressure in the enclosed volume 56. A reduction in the gas pressure within the enclosed volume 56 may result in a partial vacuum being formed in the enclosed volume 56. Thus, the pressure state produced by the reactor 16 during operation is dependent on the local acoustic pressure applied to the tissue site 20, and in particular the wound area 20a thereof (e.g., 0.2 bar sound pressure ). In one embodiment, the local acoustic pressure is a partial oxygen vacuum that absorbs oxygen from the tissue site 20. Optionally, the pressure state produced by the reactor 16 may remove or evacuate oxygen from the tissue site 20 (and, in particular, the wound site 20a), add oxygen from the tissue site 20 to the at least one other And is in a negative pressure state to remove gas (for example, nitrogen or carbon dioxide). This may have the advantage of drawing the effluent more efficiently from the tissue site 20. In addition, the negative pressure state produced by the reactor 16 can cause the reactor 16, whereby the entire wound treatment device 10 is stimulated toward the tissue site 20. [ Also advantageously, limited heat from the reactor can be used to help heal at the tissue site (e.g., to prevent infection).

In particular, the reactor 16 may be positioned in the enclosed volume 56 and configured to react with a selected gas found in the air. In one embodiment, as the reactor 16 consumes the selected gas in the enclosed volume 56, the gas pressure in the enclosed volume 56 is reduced. For example, if the reactor 16 consumes oxygen, there may be approximately a 20% reduction from the atmospheric pressure of the enclosed volume 56. An example of a reactor 16 that may be used in the wound treatment device 10 is described in US 2014/0109890 A1, which is incorporated herein by reference. US 2014/0109890 A1 describes an oxygen-based heater; However, the oxygen-based heater described in US 2014/0109890 A1 can be used as a reactor 16 that produces a partial vacuum in the enclosed volume 56 by consuming oxygen in the enclosed volume 56. In this example, the reactor 16 comprises a reducing agent, a catalyst for the reduction of oxygen such as carbon, a binder and an ionic conductive solution or electrolyte solution, which may be applied onto the reactor substrate 80. The reducing agent on the reactor substrate 80 may be, for example, zinc, aluminum, or iron. This can be regarded as a chemical pump and / or a non-electrochemical cell reactor in which current is not flowing there.

Advantageously, the reactor 16 may be biocompatible. For example, the reactor 16 may be such that it is suitable for use in close proximity and / or in contact with the skin of the subject. Also, for example, the reactor 16 may be pH neutral. For example, the reactor 16 may have a pH between about 6 and about 8. Alternatively, the reactor 16 (e.g., reactor substrate 80) may be provided as a flexible reactor. For example, the substrate 80 may include agents arranged or provided to increase the flexibility of the substrate (e.g., the agents may be arranged in rows). As described above, the reactor 16 may comprise an electrolyte solution, which may be a water soluble electrolyte solution. This can advantageously facilitate maintenance of the moist environment at the tissue site 20, and particularly at its wound site 20a. Additionally or alternatively, the aqueous electrolyte solution may be provided in the reactor housing element 14 (e.g., as absorbed into a gel or a separate sponge not shown).

The release layer 7 on the lower surface 62 of the reactor housing element 14 is in contact with the selected gas (for example, water) until the airtight barrier, which is the release layer 70 in the illustrated embodiment, is removed from the reactor housing element 14 , Nitrogen, oxygen, carbon dioxide, etc.) may be excluded from access to the reactor 16. Alternatively, the reactor 16 may be provided as a package, which is shown in FIG. 1 as comprising an upper layer 84 and a lower layer 86. The top layer 84 adheres to the bottom layer 86 to surround the reactor substrate 80 therebetween to provide an air-type seal such that selected gases are excluded from access to the reactor 16. [ The upper layer 84 and / or the lower layer 86 may operate as a hermetic barrier and such removal of the upper layer 84 from the lower layer 86, or vice versa, In part, the selected gas (e.g., oxygen) is allowed to approach the reactor 16 such that the selected gas can be consumed by the reactor 16.

Alternatively, at least one of the layers (lower layer 86 in the illustrated embodiment) may include openings 88 and sealing layer 90 may comprise a lower layer 86 covering openings 88, In an airtight manner. Removal of the sealing layer 90 from the lower layer 86 exposes the reactor 16 to the selected gas through the openings 88 which allows the reactor 16 to consume the selected gas in the enclosed volume 56 . The surface area of the openings 88 can be roughly scaled to control the flow of selected gases through the openings 88. This may maintain the chemical reaction of the reactor 16 to a desired time limit for maintaining a desired pressure state on the tissue site 20 for a desired period of time (e.g., 12 hours, 24 hours, etc.). Additionally or alternatively, the number and / or size of the openings 88 can be selected to control or limit the rate of consumption of the reactor, thereby controlling the pressure state produced by the reactor and / Thereby controlling the amount of heat being generated. Additionally or alternatively, a plurality of sealing layers 90 may be formed by removing one or a select few of the sealing layers (while the other sealing layers are still attached to the bottom layer 86) To limit the flow of water.

Additionally, the wound treatment device 10 may be provided on the reactor housing element 14, and in particular on the hood 58 of the reactor housing element 14, to further control the pressure within the enclosed volume 56. [ (Not shown). The pressure release valve 92 may allow selected communication between the enclosed volume 56 and the surroundings. The pressure release valve 92 can be operated when a predetermined pressure difference exists between the sealed volume 56 and the surroundings.

In one embodiment, wound treatment device 10 may be packaged such that reactor housing element 14 and reactor 16 are packaged separately from skin contact element 12, but this is not required. In such an embodiment, release layers 50 and 70 are removed from skin contact element 12 and reactor housing element 14, respectively. Removal of the release layer 70 may expose the reactor 16 and thereby actuate the reactor 16, as indicated above. Alternatively, the release layer 70 can be removed by removing the release layer 70 from the reactor housing element 14 to cause removal of the lower layer 86 from the upper layer 84 and thereby actuating the reactor 16 And may be attached to the lower layer 86 to expose the reactor 16. The release layer 70 causes removal of the release layer 70 from the reactor housing element 14 to cause removal of the seal layer or layers 90 from the underlying layer 86 and thus the removal of the reactor 16 And may be attached to the sealing layer 90 to expose it to air through openings 88 provided in the lower layer 86. After removal of the release layer 70 from the reactor housing element 14, the lower surface 62 of the reactor housing element 14 is connected to the reactor housing element 14 and the skin (not shown) via, for example, a seal 66 and an adhesive 68. [ May be in contact with the interface surface (32) of the skin contact element (12) which substantially provides a hermetic seal between the contact elements (12).

In addition, the reactor housing element 14 may be connected to the reactor 16 (for example, to allow the reactor housing element 14 to adhere to the skin contact element 12) to be interposed between the reactor 16 and the skin- Permeable membrane 100, referred to herein as an air-permeable liquid impermeable membrane, which is arranged on an exposed surface (i.e., a surface facing the tissue site 20) . The membrane 100 may function to inhibit or limit exudate aspirated from the tissue site 20 into reaching the reactor 16, and in particular, the reactor substrate 80, thereby preventing the efficacy or operational capability of the reactor 16 Interferes with. The size (i.e., surface area) of the liquid impermeable-air permeable membrane 100 may depend on the location of the liquid impermeable-air permeable membrane 100 in the wound treatment device 10. [ Once the effluent from the tissue site 20 is in contact with the reactor substrate 80, the chemical reaction of the reactor 16 upon contact with the selected gas can be compromised. Thus, the membrane 100 permits air flow between the tissue site 20 and the reactor 16, eliminating or at least inhibiting the effluent from contacting the reactor 16. By way of example, the membrane 100 may be a polytetrafluoroethylene film, such as Gore-Tex® or similar material.

The liquid impermeable-air permeable membrane 100 may be positioned at different locations in the wound treatment device 10. [ In one example, the liquid impermeable-air permeable membrane 100 may be positioned between the reactor substrate 80 and the lower layer 86, which constitutes a hermetic package for the reactor 16. Permeable membrane 100. Thus, when the lower layer 86 (or the sealing layer 90) is removed, the air can access the reactor 16, but the exudate from the tissue site 20 is directed to the liquid impermeable- Will be excluded or at least prohibited. In another example, the liquid impermeable-air permeable membrane 100 can be positioned between the lower layer 86 (or the sealing layer 90) and the wicking element 36 that make up the airtight package for the reactor 16 have.

In one embodiment, where the reactor housing element 14 and the reactor 16 are packaged separately from the skin contact element 12, the release layer 70 can be removed from the reactor housing element 14. The removal of the release layer 70 from the reactor housing element 14 may expose the reactor 16 to air by removal of the lower layer 86 and the sealing layer 90, Can be attached to the reactor housing element 14 in an airtight manner so that air is excluded from access to the reactor 16 until the layer 70 is removed from the reactor housing element 14. [ After removal of the release layer 70 from the reactor housing element 14 the lower surface 62 of the reactor housing element 14 is removed from the skin contact element 12 (e.g., after the release layer 50 has been removed from the skin contact element 12) ) To the skin-contacting element (12).

In an alternative embodiment, the wound treatment device 10 may be pre-assembled with a reactor housing element 14 already attached to the skin contacting element 12. In this embodiment, the release layer 70 may be omitted and the lower layer 86 may be provided to allow communication therethrough to the reactor 16 when the seal layer 90 is included (e.g., May be excluded). Removal of the release layer 44 may serve to operate the reactor 16.

In a further embodiment, the reactor housing element 14 and the reactor 16 are configured to allow the replacement of the reactor housing element 14 and the reactor 16 without removal of the skin contact element 12 from the tissue site. May be removably attached to the contact element 12. In addition, the wicking element 36 may be attached to the tissue site for replacement of the wicking element 36 (e.g., when the wicking element is saturated beyond a predetermined amount with the exudate) May be removable from the contact element (12). In one example, the reactor housing element 14, the reactor 16, and the wicking element 36 can be replaced at the same time without replacement of the skin contact element 12. In another embodiment, only one or the other of the reactor housing element 14 (and reactor 16) or wicking element 36 may be removed or replaced.

In certain embodiments, the wound treatment device 10 may be designed to illustrate specific operating and / or design parameters. Such pyramids include, for example, a maximum effusion volume to be included by the wound treatment device 10 (e.g., by the wicking element 36), a velocity of the effluent removed from the tissue site, a desired sound pressure (e.g., 0.2 bar sound pressure), the service time for the wound treatment device 10 (i.e., the amount of time between band exchanges), the expected efficiency of the reducing agent (e.g., zinc) The rate of utilization, the amount of reducing agent (and thus the gas scavenging capacity of the device 10), and the like. As an example, a tissue volume 20 of about 10 cm x 20 cm and an offset of about 2.5 cm hood 58 (or the top of the reactor housing element 14) from the tissue site 20 is in an enclosed volume 56). The wicking element 36 and any other solid components (e.g., liquid impermeable-air permeable membrane 100) within the enclosed volume 56 occupy 100 mL in the enclosed volume 56 It is assumed that there may be 400 mL of air in the enclosed volume 56 (before the effluent of the second portion 56 is drawn into the enclosed volume 56). 400 mL of air is introduced into the enclosed volume 56 before the application of the partial vacuum from the reactor 16 consumes the selected gas of air in the enclosed volume 56 and before any effluent is sucked into the device 10. [ Standard temperature and pressure (STP) of about 320 mL of nitrogen and about 80 mL of oxygen. In practical applications, the size of the tissue site 20, offset, and enclosed volume can be varied, It can be much smaller than the example.

One gram (1 gram) of zinc (Zn) has a capacity to consume about 170 mL of STP in oxygen (O ₂ ), which is the amount of oxygen at about 850 mL (STP) of normal dry air. The seals 40 and 66 may be provided but there may be leakage of ambient air into the enclosed volume 56 past the seals 40 and 66 and the reactor housing element 14 and skin contact element 12 There may be spreading through. For purposes of this disclosure, both leakage past boundaries (e.g., leakage around seal 40) and diffusion (e.g., diffusion through reactor housing element 14) will be referred to as leakage. The seals 40 and 66, the skin contact element 12 and the reactor housing element 14 may be configured to have a maximum leakage rate of air into the enclosed volume 56 from the surroundings. For example, the maximum leakage rate of 1 mL (STP) / hour of air into the enclosed volume from the surroundings causes an oxygen / time of 0.2 mL (STP). Since 1 g of zinc consumes 170 mL of oxygen (STP), 1 g of zinc is suitable for causing a 20% reduction from normal atmospheric pressure in the enclosed volume 56 for a long period of time, for example, well over 72 hours Thereby providing a positive reducing agent. This explains that the effluent is sucked into the device 10 from the tissue at a rate of about 0.5 mL to 1 mL per hour. As will be appreciated by those skilled in the art, the reactor 16 may not operate to provide a total utilization of a given amount of reducing agent, and thus an efficiency factor needs to be considered.

In view of the foregoing, and by way of example only, the wound treatment device 10 may be constructed as follows. The reactor 16 can be configured to have a predetermined scavenging capacity ("SC"), which relates to the volume of the selected gas that the reactor 16 is configured to consume. For example, as described above, 1 g of zinc will consume about 170 mL of oxygen (STP), and thus the desired capacity will be 170 mL. The enclosed volume 56 is defined by the area of the tissue site 20, the reactor housing element 14 (not shown), the reactor 16, and any other solid components in consideration of the wicking element 36 in addition to the reactor 16 and any other solid components within the enclosed volume 56 ), A determined volume ("DV ") based on the offset of the hood 58 (or the top of the reactor housing element 14) from the tissue site 20 For example, The wound treatment device 10 may be configured to have a maximum leakage rate (LR) for air entering the enclosed volume 56. In addition, (10) may be configured to have a minimum wear time ("MWT"), which relates to the minimum amount of time that the wound treatment device 10 is configured to wear. Consuming or scavenging selected gases during wear time Assuming that it is desirable, the wound treatment device may be constructed in consideration of the following relationship:

SC> DV ^* (% of selected gas in air) + LR ^* (% of selected gas in air) ^* MWT.

The scavenging capacity can be configured to provide a relatively small reactor 16 with respect to the reactor housing element 14 and the tissue site 20 to be treated. The determined volume can be configured to provide a relatively small reactor 16 and reactor housing element 14 in view of the tissue site 20 to be treated. The maximum leakage rate for air entering the enclosed volume 56 may be reduced as much as practically; However, there may be some situations where a predetermined leakage amount is desirable, for example, when circulation of pressure within the enclosed volume 56 is desired. For example, the maximum leakage rate for air entering the enclosed volume 56 may be less than 10 mL / hr, and preferably less than 1 or 2 mL / hr. The minimum wear time can be determined based on the desired amount of time that the localized negative pressure will be applied to the tissue site 20. [ For example, the minimum wear time may be at least 72 hours, at least 48 hours, at least 24 hours, at least 12 hours, at least 8 hours, or at least 4 hours. Manufacturing tolerances, differences between tissue sites, and safety factors (e.g., the multiplier on the right side of the above relationship) to accommodate those who place the wound treatment device 10 on the tissue site 20 May be desirable.

As the reactor 16 consumes the selected gas found in the air in the enclosed volume 56, the exothermic reaction occurs so that the reactor 16 consumes the selected gas in the enclosed volume 56. The gas pressure within the enclosed volume 56 may be reduced, for example, if the reactor 16 consumes oxygen, and there may be a reduction of about 20% from the atmospheric pressure of the enclosed volume 56. The electrolyte selected for the reactor 16 is maintained at a pressure of 0.8 bar (i.e., 0.2 bar negative pressure or about 150 mmHg) in a closed volume for up to 8 hours, preferably up to 12 hours, and more preferably up to 24 hours up to 72 hours ). ≪ / RTI >

Optionally, the reactor housing element 14 may also have a removable section 160 that can provide access to the reactor 16 when removed. This will allow for the substitution of the reactor 16 independently of the reactor housing element 14. Alternatively, the removable section will allow additional ambient air access to the reactor 16 or additional reactor located below the reactor housing element 14. [ For example, the removable section 160 may be attached to the top layer 84 of the package in which the reactor substrate 80 is located. Removal of the removable section 160 may expose the reactor substrate 80 to ambient air by causing removal of at least a portion of the top layer 84, which will cause an exothermic reaction. Alternatively, an additional reactor (not shown) may be located below the reactor housing element 14 and removal of the removable section 160 may be accomplished by the package (top layer 84 and bottom layer 86) Package) to expose the additional reactor to ambient air.

Different types of reactors may be used to provide localized negative pressure inside the enclosed volume 56 of the wound treatment device 10. [ FIG. 3 shows a reactor 216 that may be used in place of the reactor 16 shown in FIG. Reactor 216 may comprise a plurality of reactor substrates or a plurality of regions on the same reactor substrate, each of which may comprise reactor elements 80a, 80b and 80c, each having different chemical properties and / do. For example, the first reactor element 80a can be configured to begin to consume oxygen after being exposed to oxygen in a very short (first) period t1, for example, almost instantaneously. The second reactor element 80b may be configured to begin to consume oxygen after exposure to oxygen for a longer (second) period t2 and the third reactor element 80c may be configured to begin to consume much longer ), And then begin to consume oxygen after exposure to coral. Such a configuration may allow circulation of pressure in the enclosed volume 56.

Instead of a reactor consisting of a reactor substrate 80, the reactor 16 can be an electrochemical pump, vacuum-on-demand devices (referred to herein as VOD), electrolytic cells, State devices, oxygen absorbing iron packets or getters of zirconium titanium, vanadium iron, lithium, lithium metal, magnesium, calcium, lithium barium combinations, zinc-air batteries, zinc-air battery components or selected gases, And other materials that are highly reactive with nitrogen, carbon dioxide, and oxygen gases found in wound bed environments.

FIG. 4 shows another reactor 226 that may be used in place of the reactor 16 shown in FIG. WO 2015/054040 A1, which is incorporated by reference, describes an electrochemical cell adapted to consume gases in the enclosure via an electrochemical reaction, i. E., Air or its gaseous non-noble metal components. Consumption of this gas in the enclosed enclosure forms a partial vacuum. The wound healing device 10 is configured to lower the pressure within the enclosed volume 56 through an electrochemical reaction that occurs when a voltage is applied to the electrochemical cell 228 by the power supply 230 (shown schematically at 4) And may include such a reactor 226 having an electrochemical cell 228. The operation of this example of electrochemical cell 228 can also be accomplished by controlling the current supplied to the electrochemical cell 228 by the power supply 230, for example by providing a switch 232 that can be manipulated by the user . The power source 230 may be located in the enclosed volume 56 or external to the wound treatment device 10 (e.g., on the reactor housing element 14). The switch 232 may be provided outside the wound treatment device 10 (e.g., on the reactor housing element 14).

In the example where the reactor is a VOD device, VOD is a solid state electrochemical cell, which, when charged with a low current, produces a highly reactive material that captures atmospheric gases and forms a partial vacuum when sealed with an airtight system can do. In a VOD device, the metal is deposited to grow dendrites as voltages are applied across the electrodes of the VOD device and the lithium salt electrolyte, filling the VOD device. Similar to charging a battery, electrons are transferred from layer to layer to form metallic lithium.

In the example where the reactor is a getter, the getter known in the art is a deposition of the reactor material used to initiate and maintain the partial vacuum. In particular, when the gas molecules impinge on the getter material, the gas molecules (i.e., the molecules of the selected gas) are combined with the getter chemically or by adsorption. Thus, the getter removes the selected gas from the vacuum space until the active material is exhausted.

A reactor having a self-regulating oxygen getter driven by a zinc-air battery technology may be used in place of the reactor 16 described above comprising the reactor substrate 80. Zinc-air batteries can self-regulate a partial vacuum pressure of about 0.8 bar by reacting to control or reduce oxygen levels in the sealed area. If the zinc-air battery components are configured with a working zinc-air battery, the battery voltage will drop when oxygen is depleted and the desired vacuum pressure is achieved. This drop in voltage can be used to indicate that the desired partial vacuum has been achieved. For example, a 675 size hearing aid zinc-air battery rated at 620 mAh occupies a volume of 0.5 mL and weighs 1.9 g. The 675 zinc-air battery can remove its oxygen volume by more than 150 times.

The wound healing device 10 may also include additional powered components, illustrated as a powered component 240 shown schematically in FIG. Each powered component 240, described below with reference to FIGS. 5-7, may be, for example, a power source that can be a zinc-air battery that is exposed to the environment and can be electrically connected to the powered component 240 (Shown schematically in Figure < RTI ID = 0.0 > 1). ≪ / RTI > When a zinc-air battery is used as the power source 242, the power source 242 is located outside the enclosed volume 56 or the section of the reactor housing element 14 or the skin contact element 12 is exposed to ambient air, Lt; RTI ID = 0.0 > air battery. ≪ / RTI >

5 illustrates a heater 250, which is an example of a powered component 240 that may be used in a wound treatment device 10, which is electrically connected to a power supply 242. The heater 250 may be a thin film heater. The heater 250 may provide heat at the tissue site 20 for the purpose of reducing the likelihood of infection. The switch 252 may be provided to control power to the heater 250.

FIG. 6 illustrates a first electrode 260 and a second electrode 262 that are electrically connected to a power source 242. The electrodes are another example of a powered component 240 that can be used in the wound treatment device 10. The switch 252 may be provided to control power to the electrodes 260 and 262. The first electrode 260 is located on a first side of the tissue site 20 and can contact the skin and the second electrode 262 is positioned on a second, opposite side of the tissue site 20, Can be contacted. Electrodes 260 and 262 may be used to provide an electrical stimulus to tissue site 20.

FIG. 7 illustrates a light source 280, which is another example of a powered component 240 that may be used in the wound treatment device 10. The light source 280 may include a plurality of LEDs 282 mounted on the flexible substrate 284. The LEDs 282 are electrically connected to the power source 242. The flexible substrate 284 may be disposed adjacent the skin contacting element 12 which may include larger apertures 34 that may allow light to pass through for light therapy. Alternatively, the light source may be used to indicate that the partial vacuum state is within the enclosed volume 56. [

Optionally, the electrically driven device 240 may be a transceiver, transmitter, or receiver to enable wireless communication from the wound treatment device. Also, instead of the powered device 240, an RFID or non-powered indicator (both not shown) could be embedded with the reactor 14 in the reactor housing element 14. [

Alternatively, although not shown, the wound treatment device 10 may include an indicator that indicates the state of the pressure state produced by the reactor 16. [ For example, one or more of the wicking element 36, the reactor 14, or the skin contacting element 12 may include a rigid portion that causes the raised or elevated indicator portion to be shown through the reactor housing element 14 . If the reactor 14 produces, for example, a negative pressure state, the rigid portion will protrude or appear through the reactor housing element 14 to indicate that the partial vacuum state is within the enclosed volume 56. In one embodiment, the rigid portion can be one or more beads (and the wicking element 36 protrudes peripherally relative to the reactor 140 or is disposed above the reactor 16) disposed in the wicking element 36.

A method for applying wound treatment to a tissue site will now be described.

In particular, it should be understood that while the method will be described in connection with the wound treatment device 10 described above, other wound treatment devices may be used. In the method, referring to Fig. 8, tissue site 20 is covered with skin contact element 12 at S300. As already mentioned above, the skin contact element 12 has a skin contact surface 30 and a boundary surface 32 opposite to the skin contact surface 30. This step of covering the tissue site 20 with the skin contact element 12 further comprises a skin contact surface 30 which is arranged to face the tissue site 20.

At S302, the reactor 16 is actuated to produce a pressure state at the tissue site 20. As already described herein, activating the reactor 16 may include generating a negative pressure state at the tissue site 20. [ This may provide a suction force or partial vacuum force on the tissue site 20 where the effluent is evacuated or aspirated away from the tissue site 20 into the wound treatment device 10. [ The skin contacting element 12 may include a wicking element 36 that absorbs exudate from the tissue site 20 when the effluent is inhaled or evacuated away from the tissue site 20. [ In particular, the pressure state may be a negative pressure state where the oxygen is evacuated from the tissue site 20. Alternatively, the negative pressure state can also evacuate at least one other gas (e.g., nitrogen, carbon dioxide, etc., or any combination thereof) from tissue site 20 other than oxygen.

And the reactor housing element 14, in which the reactor 16 is received therein, is then attached to the skin contact element 12 at S304. As already described herein, the reactor housing element 14 has a lower mounting surface 62 and a top surface 64 opposite the lower mounting surface 62. In one embodiment, the step of attaching the reactor housing element 14 to the skin-contacting element 12 occurs after the step of operating the reactor 16.

As discussed above, the wound treatment device 10 may include a membrane 100. If so included, the method further includes inhibiting the effluent from the tissue site 20 from communicating with the reactor 16 in fluid communication as indicated at S306. In particular, the membrane 100 is configured such that the effluent from the tissue site 20 is evacuated through the reactor substrate 80 and the reactor pad 82 (e.g., via the wicking element 36) And / or prevent the possibility of contact with the reactor pads < RTI ID = 0.0 > 82 < / RTI >

Alternatively, the method may include removal and replacement of the reactor housing element 14 and the reactor 16 together. Additionally or alternatively, the method may also include removal and replacement of the wicking element 36. This may occur with the reactor housing element 14 and the reactor 16 or by itself. The reactor housing element 14 and the reactor 16 are temporarily unfixed from the skin contact element 12 and the wicking element 36 is replaced and then the reactor housing element 14 and the reactor 16, May be reattached to the skin contacting element 12. In these instances, the skin-contacting element 12 remains attached to the tissue site 20 and can avoid undesirable fractures at the tissue site 20. [ Also, as described above, the reactor 16 can be replaced alone or with a wicking element 36 and the reactor housing element 14 is reattached to the skin-contacting element 12.

In certain embodiments, the use of wound treatment device 10 may occur as follows. The release layer 44 may be removed from the skin contact element 12 to expose the adhesive 42 and optionally the ambient pressure seal 40. Alternatively, after removal of the release layer 44, a peripheral pressure seal 40 may be added to the skin-contacting surface 30 of the skin-contacting element 12. Covering the tissue site with the skin contact element at S300 may further include adhering and / or sealing the skin contact element 12 to and / or around the tissue site 20. In particular, such gluing and / or sealing steps may include both sealing and adhering steps through peripheral pressure seal 40 and adhesive 42.

The release layer 50 can be removed from the interface surface 32 of the skin contact element 12 while the skin contact element 12 is adhered to the tissue site 20 (or around the tissue site 20) The release layer 70 can be raised from the lower surface 62 of the reactor housing element 14. Removal of the release layer 70 may also include operation of the reactor 16, which is received by the reactor housing element 14, as previously described herein. The removal of the release layer 70 from the reactor housing element 14 also serves to expose the adhesive 68 and optionally the peripheral pressure seal 66 provided on the lower surface 62 of the reactor housing element 14 can do. Alternatively, the peripheral pressure seal 66 may be applied or provided on the lower surface 62 of the reactor housing element 14 after the release layer 70 has been removed. Attaching the reactor housing element 14 to the skin contact element 12 at S304 may further include bonding and / or sealing the reactor housing element 14 to the skin contact element 12. In particular, such steps of bonding and / or sealing the reactor housing element 14 to the skin contact element 12 may include both sealing and bonding through the peripheral pressure seal 66 and the adhesive 68.

Alternatively, the method may include introducing a gas (e.g., hydrogen) from the reactor housing element 14 into the atmosphere through the reactor housing element 14 that is at least partially gas permeable (e.g., at least partially carbon dioxide or nitrogen- For example, nitrogen, carbon dioxide, or the like, or any combination thereof).

It will be appreciated that various of the above and other features and functions, or alternatives or variations thereof, may be combined into many other different systems or applications. In addition, various such presently unexpected or unexpected alternatives, modifications, variations, or improvements therein, which are also intended to be covered by the following claims, may be subsequently made by those skilled in the art.

Claims (51)

A wound treatment device,
A skin contact element configured to cover an associated tissue site, the skin contact element comprising: a skin contact element having a skin contact surface and an interface opposite the skin contact surface;
A reactor for generating a pressure state at the associated tissue site in operation; And
Wherein the reactor housing element has a lower mounting surface and an upper surface opposite the lower mounting surface, the reactor housing element being configured to receive the skin contact element after the reactor is actuated, The wound treatment device being configured to be attached. The method according to claim 1,
Wherein the reactor housing element comprises an air permeable liquid impermeable membrane arranged on an exposed surface of the reactor such that the reactor housing element is interposed between the reactor and the skin contact element when the reactor housing element is attached to the skin contact element. . 3. The method of claim 2,
Wherein the membrane is packaged with the reactor. 4. The method according to any one of claims 1 to 3,
Further comprising at least one skin adhesive or sealing element disposed on the skin contacting surface of the skin contacting element for adhering or sealing the skin contacting element to and / or around the associated tissue site. 5. The method of claim 4,
Wherein the at least one skin adhesive or sealing element comprises an ambient pressure seal sealing the skin contact element about the associated tissue site so that the pressure condition produced by the reactor is applied to the associated tissue site. 5. The method of claim 4,
Wherein the at least one skin adhesive or seal element comprises an adhesive that adheres the skin contact element to and / or around the associated tissue site. 4. The method according to any one of claims 1 to 3,
Further comprising at least one reactor adhesive or sealing element interposed between the skin contact element and the reactor housing element for adhering or sealing the reactor housing element to the skin contact element. 8. The method of claim 7,
Wherein the at least one reactor adhesive or sealing element comprises an ambient pressure seal sealing the reactor housing element to the skin contact element. 8. The method of claim 7,
Wherein the at least one reactor adhesive or seal element comprises an adhesive that bonds the reactor housing element to the skin contact element. 4. The method according to any one of claims 1 to 3,
Wherein the skin contact element comprises a skin contact element opening extending from the skin contact surface to the interface and the skin contact element opening is arranged such that the pressure condition is applied to the associated tissue site through the skin contact element opening Wound treatment device. The method according to claim 1,
Wherein the wicking element is interposed between the reactor and the associated tissue such that the pressure condition is applied to the associated tissue site via a wicking element. 12. The method of claim 11,
Wherein the wicking element absorbs exudate from the associated tissue site when the pressure state is in a negative pressure state to evacuate oxygen from the associated tissue site. 12. The method of claim 11,
Wherein the wicking element is disposed between a skin contacting surface of the skin contacting element and a wound contacting element attached to the skin contacting surface of the skin contacting element. 12. The method of claim 11,
Wherein the wicking element is disposed between the interface of the skin contact element and the reactor. The method according to claim 1,
Wherein the pressure state produced by the reactor in operation is a local negative pressure applied to the associated tissue site. 16. The method of claim 15,
Wherein the localized negative pressure is a partial oxygen vacuum that absorbs oxygen from the associated tissue site. The method according to claim 1,
Wherein the reactor housing element is nitrogen-gas permeable to evacuate nitrogen gas from the associated tissue site to the outside atmosphere. The method according to claim 1,
Further comprising a skin contact element release layer disposed on the skin contact surface of the skin contact element, wherein the skin contact element release layer comprises a removable wound to expose an adhesive provided on the skin contact surface of the skin contact element, Treatment device. 19. The method of claim 18,
And a wound contact element disposed interposed between the skin contact surface and the skin contact element release layer. The method according to claim 1,
Further comprising a reactor housing release layer disposed over and above the lower attachment surface of the reactor housing element to inhibit operation of the reactor, wherein the reactor housing release layer is disposed on the reactor housing element to actuate the reactor And wherein the device is removable to expose the reactor accommodated by the wound. 21. The method of claim 20,
Further comprising an interface release layer disposed over the interface surface of the skin contact element to provide the skin contact element as a first package component and the reactor housing element and the reactor as a second package component. device. The method according to claim 1,
The package further comprising a plurality of airtight barriers selectively removable from the package, wherein the reactor is disposed within the package and the selected gas is introduced into the package until at least one of the plurality of airtight barriers is removed from the package A wound treatment device excluded from access to the reactor. 9. The method of claim 8,
Wherein the reactor comprises a plurality of reactor elements. The method according to claim 1,
Wherein the pressure state produced by the reactor is a negative pressure state that removes oxygen from the associated tissue site and removes at least one other gas from the associated tissue site in addition to the oxygen. The method according to claim 1,
Wherein the reactor comprises a reactor substrate and a reducing agent, a binder, and an ionic conductive solution. The method according to claim 1,
The reactor may be a chemical pump, an electro-chemical pump, a vacuum-on-demand device, an electrolyzer, a reduced-pressure solid state device, an oxygen absorbing iron packet, a zinc-air battery, Vanadium iron, lithium, lithium metal, magnesium, calcium, lithium barium combinations, or any combination thereof. The method according to claim 1,
The reactor is a biocompatible wound treatment device. The method according to claim 1,
Wherein the reactor is pH neutral. 25. The method of claim 24,
Wherein the pH of the reactor is between about 6 and about 8. The method according to claim 1,
And a power source mounted to the reactor housing element. 31. The method of claim 30,
Wherein the power source is a zinc-air battery exposed to the environment. The method according to claim 1,
The reactor is configured to have a predetermined scavenging capacity (SC) for the selected gas, and the enclosed volume defined by the reactor housing element in which the reactor is housed, determines the determined volume (DV) Wherein the wound treatment device is configured to have a maximum leakage rate (LR) for air entering the enclosed volume, and wherein the wound treatment device is configured with a minimum wear time (MWT) :
SC> DV ^* (% of selected gas in air) + LR ^* (% of selected gas in air) ^* MWT. The method according to claim 1,
Wherein the reactor housing element is removably attached to the skin contact element to enable removal of the reactor housing element and replacement of one or both of the reactor and the reactor housing element. The method according to claim 1,
Further comprising a wicking element interposed between said replaceable reactor and said associated tissue when said reactor housing element is removed from said skin contacting element. A wound treatment device,
A skin contact element configured to cover an associated tissue site, the skin contact element comprising: a skin contact element having a skin contact surface and an interface opposite the skin contact surface;
A reactor for generating a pressure state at the associated tissue site in operation; And
Wherein the reactor housing element has a lower mounting surface and an upper surface opposite the lower mounting surface, and wherein the reactor housing element (14) is adapted to receive its replacement when removed And a removable section that provides access to the reactor. A wound treatment device,
A skin contact element configured to cover an associated tissue site, the skin contact element comprising: a skin contact element having a skin contact surface and an interface opposite the skin contact surface;
A reactor for generating a pressure state at the associated tissue site in operation;
A reactor housing element for receiving the reactor, the reactor housing element having a lower mounting surface and an upper surface opposite the lower mounting surface; And
Permeable liquid impermeable membrane arranged on an exposed surface of the reactor such that the reactor housing element is interposed between the reactor and the skin contact element when the reactor housing element is attached to the skin contact element. 37. The method of claim 36,
Wherein the reactor housing element is configured to attach to the skin contact element after the reactor is activated. 37. The method of claim 36,
Wherein the skin contact element is packaged separately from the reactor and the reactor housing element. 37. The method of claim 36,
Wherein the skin contact element is packaged with the reactor and the reactor housing element such that removal of the release layer from the backside of the skin contact element activates the reactor. 37. The method of claim 36,
Wherein the reactor housing element is removably attached to the skin contact element to enable removal of the reactor housing element and replacement of one or both of the reactor and the reactor housing element. 41. The method of claim 40,
Further comprising a wicking element interposed between the replaceable reactor and the associated tissue site when the reactor housing element is removed from the skin contact element. A wound treatment device,
A skin contact element configured to cover an associated tissue site, the skin contact element comprising: a skin contact element having a skin contact surface and a boundary surface opposite the skin contact surface;
A reactor for generating a pressure state at the associated tissue site in operation;
And a reactor housing element for receiving the reactor, the reactor housing element having a lower mounting surface and an upper surface opposite the lower mounting surface,
Wherein the reactor housing element is removably attached to the skin contact element to enable removal of the reactor housing element and replacement of one or both of the reactor and the reactor housing element. 43. The method of claim 42,
Further comprising a wicking element interposed between the replaceable reactor and the associated tissue site when the reactor housing element is removed from the skin contact element. 43. The method of claim 42,
Permeable liquid impermeable membrane arranged on an exposed surface of the reactor so as to be interposed between the reactor and the skin contact element when the reactor housing element is attached to the skin contact element. 31. The method of claim 30,
And a heater electrically driven by the power source. 46. The method of claim 45,
Wherein the heater is a thin film or thin film nanowire heater. 31. The method of claim 30,
Wherein the power source is a zinc-air battery or a zinc MnO ₂ battery that is exposed to the surroundings in electrical communication with the thin film heater. 31. The method of claim 30,
Further comprising a first electrode and a second electrode electrically connected to the power source. 31. The method of claim 30,
Further comprising a light source for providing light therapy to the tissue site. 43. The method of claim 1, 36 or 42,
Wherein the reactor housing element (14) comprises a removable section that, when removed, provides access to the reactor for its replacement. 43. The method according to any one of claims 1, 35, 36 or 42,
Wherein at least one of the reactor or the reactor housing element comprises a water soluble electrolyte solution to maintain a wet state at the tissue site.

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